Medical equipment RA QA Engineer

1 day ago

bangalore, India Althion Full time

Job descriptionAlthion is a Hyderabad based med-tech/water-tech company developing and manufacturing an exciting portfolio of medical devices and equipment. With initial R&D and manufacturing set-up funded by BIRAC, and solid traction in India for its line of kidney dialysis grade ultra-pure water products, Althion is now well positioned to expand to other markets. We are looking to strengthen our manufacturing processes and R&D program in our world-class facility.QA Engineer Keywords: QA, certifications , medical equipment R&D and manufacture, healthcareQualifications and Experience:Education: BE (Mech)/ MTech (Mech) or similarExperience: 3 to 8 years proven experience in similar role knowledge in the medical device/manufacturing domain is mustExcellent communication skills.Ability to work independently and in a team environment.Responsibilities• Responsible for incoming inspection, in process inspection, final inspection, testing, trial run and PDIR.• Implementation of ISO 13485, CDSCO, BIS, CE marking, IEC 60601, etc. Handle entire documentation requirement for all certifications.• As an MR, Plan, conduct internal audits and to follow up for NC closures.• Conduct trainings as and when required in consultation with other HODs to achieve quality standards.• Liaison with external agencies (certification body, consultants) on matters pertaining to QMS and other certifications.• Ensuring and facilitating supplier audit, tool audit, 5S audits conducted on-time.• Identifying the inspected items/materials/products with Colour coding• Responsible for documenting the inspection & testing records/reports.• Responsible for getting approval for the deviations observed on products/materials/components etc.• Responsible for maintaining calibration of measuring instruments/equipments.• Responsible for Process achievement (KPI) in QA/QC Department.• Contribution in machine trials & proving with R&R study, Cp & Cpk calculations.• Problem solving with 8D methods.• Knowledge about TQM, QMS, SPC/SQC ,7QC Tools, CAPA & inspection sampling methods etc.• Lead or participate in quality-related projects, such as Kaizen activities and Poka yoke.Attractive package with ESOPs and performance incentives

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